NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	57-14-7
Chemical Name	1,1-Dimethylhydrazine
Substance ID	m-nite-57-14-7_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified	- -	-	-	The substance does not fall under Explosives since it is classified into Division 6.1, subsidiary risks 3,8 PG I though it is hydrazines and contains chemical groups (adjacent nitrogen atoms) associated with explosive properties.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Since its flash point -15 degC (closed-cup) (ICSC (2008)) is < 23 degC and initial boiling point 63 degC (ICSC (2008)) is > 35 degC, the substance corresponds to Category 2.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group associated with explosive properties (hydrazines) present in the molecule. However, because it is classified in Division 6.1, Subsidiary Risk 3 and 8 (UN1163) in UNRTDG and does not correspond to hazards of the highest precedence, self-reactive substances and mixtures, it was classified as Type G.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	Since its autoignition temperature is 249 degC (ICSC (2008)), it is considered that the substance does not ignite at room temperature.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to liquid substance of low-boiling point are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	The rat LD50 values of 122 mg/kg bw (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008), PATTY, 5th (2001)), 250 mg/kg bw (PATTY, 5th (2001)) and 360 mg/kg bw (PATTY, 5th (2001)) were reported. The two of them corresponded to Category 3 and the other corresponds to Category 4. The substance was classified as Category 3, as the majority of a number of data corresponded to it.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	Based on the rabbit LD50 value of 1060 mg/kg bw (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008), ACGIH-TLV (1993) and PATTY, 5th (2001)), the substance was classified as Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on the rat LC50 value of 0.620 mg/L/4hrs (252 ppm/4hrs) (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 8 (2010), Initial Risk Assessment Report (NITE, CERI, NEDO) (2008), ASTDR (1997) and PATTY, 5th (2001)), the substance was classified as Category 2. Since 0.620 mg/L is lower than 90% of the saturated vapor pressure concentration (507.8 mg/L), the test substance was treated as "vapor hardly coexisting mists" and the criterion values for gas were adopted.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	As for the effects on humans, it was reported that the substance was irritating to eyes, skin and respiratory tract, and caused reddening and pain by contact with eyes and skin (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) Vol. 8 (2010)). In the skin irritation studies using rabbits or guinea pigs, slight erythema was seen following application of small amounts of the substance (PATTY, 5th (2001)). Based on the information, the substance was classified as Category 2. The substance was classified as "R34" in the EU risk phrases (EC-JRC (ESIS) (Access on Dec. 2010)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	As for the human effects, it was reported that the substance was irritating to eyes, skin and respiratory tract, and caused reddening and pain by contact with eyes and skin (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol.8 (2010)). In the eye irritation study using rabbits, mild conjunctivitis, and slight erythema were observed, but symptoms disappeared completely within 5 days (PATTY, 5th (2001)). The substance was classified as Category 2 based on the report that no permanent ocular damage was seen in rodent eyes (PATTY, 5th (2001)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1 in accordance with the GHS Classification Guidance for the Japanese Government. Also, based on the new evaluation, the classification result was changed. [Evidence Data] (1) The Japan Society For Occupational Health (JSOH) classified hydrazine (CAS RN 302-01-2) and its compounds in occupational skin sensitizers Group 1 (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2021)). [Reference Data, etc.] (2) No data are available for this substance. However, the analogous compound hydrazine is classified as a skin sensitizer on human data. There is a possibility of cross sensitization to hydrazine and its salts (AICIS IMAP (2014)). (3) In the DFG MAK, it was classified as Sh (danger of sensitization of the skin) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2010), List of MAK and BAT values 2020 (Accessed Nov. 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	The substance was classified as Category 2 based on the positive results in the micronucleus test using mouse liver and in the micronucleus test using mouse spleen (in vivo mutagenicity test in somatic cells) (Initial Risk Assessment Report (NITE, CERI, NEDO (2008), IARC 71 (1999)). As relevant information, positive results were reported in the micronucleus test using mouse sperm (negative results were also obtained with bone marrow micronucleus in the same test, which leads contradiction of the results), and in the DNA strand damage/break test using mouse lung and DNA binding assay using rat liver (in vivo genotoxicity test in somatic cells). As for in vitro studies, positive results were reported in the Ames test (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)), chromosome aberration tests using Chinese hamster CHL cells and CHO cells (Initial Risk Assessment Report (NITE, CERI, NEDO) Ver.1.0, No.217 (2008), IARC 71 (1999)) and gene mutation tests using mouse lymphoma L5178Y cells and Chinese hamster V79 cells (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008), IARC 71 (1999)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	The substance was classified as Category 2 based on the criteria of "Group 2B" in the carcinogenicity assessment of the IARC (IARC 71 (2001)), "RAHC" in the NTP (NTP RoC, 11th (2004)), "A3" in the ACGIH (ACGIH-TLV (2010)), "B2" in the EPA (EPA RED (2009)), "Category 2" in the EU and "Group 2B" in Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2010)). As relevant information, in the administration tests via drinking water using mice, rats and hamster, tumors of blood vessels, lungs, kidney and liver and lung cancers with remarkable shortening survival period in mice, liver tumors in rats, and vascular and cecum tumors in hamster were reported (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). In the 6-month inhalation test using mice and rats, the increases of angiosarcoma and Kupffer cell sarcomas in mice and the increases of lung adenomas, squamous cell carcinomas, pancreatic islet cell carcinomas, fibrous histiocytomas, chromophobe adenomas in rats were reported, however, these tumors might be induced by 0.12% dimethylnitrosamine involved in this substance (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In the developmental toxicity study in pregnant rats intraperitoneally administered during the organogenetic period, it was reported that reduced body weight gain of dams, reduced fetal weight and increased resorption were observed, but there was no teratogenicity (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). As for the sperm morphological effects after intraperitoneal injection in male mice, inconsistent results that one showed increased abnormality, the other no abnormalities (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). For reproductive/developmental toxicity, no other data by direct exposure of this material were available. Resorption was observed at the high dose level that maternal body weight reduced, and this data was obtained from the study by intraperitoneal injection. Therefore, the substance was classified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system, respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	As for human health effects, it was reported that although exposure concentrations were unknown, by inhalation exposures, symptoms such as respiratory effects, nausea, vomiting, neurological effects and pulmonary edema were observed (PATTY, 5th (2001)), and that the substance revealed coma and effects on the central nervous system by dermal exposure with a large amount of the substance (ATSDR (1997)). Based on the information, the substance was classified as Category 1 (nervous system, respiratory organs). In addition, it was reported that the main symptoms following acute exposure in animal studies was the effects on nervous system such as vomiting and convulsions, and that pulmonary edema and hemorrhage that were considered as secondary effects attributed to hyperglycemia or convulsions were observed in macroscopic pathological examination (Initial Risk Assessment Report (NITE, CERI, NEDO), Ver.1.0, No. 217 (2008))).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, blood system, nervous system, respiratory system)	Danger	H372	P260 P264 P270 P314 P501	In the investigation cases of workers exposed to the substance, hepatic effects such as increased serum ALT activity and fatty degeneration of the liver, etc. were reported (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol.8 (2010)). The effects on the liver were also reported in workers exposed to the substance during the works to fill the liquid fuel for rockets, which included elevations in serum ALT in 46 workers, and in 26 of them who received liver biopsy examinations, fatty degeneration in the liver was confirmed in 6 workers (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008))). As described above, based on the results of multiple human case reports, the substance was classified as Category 1 (liver). While in the repeated inhalation studies in rats, mice and dogs, clinical signs such as tremor, lethargy and dyspnea etc. were observed in mice and rats exposed at 75 ppm (as vapors) for 6 - 7 weeks (converted concentration as that of 90-day study: approx. 0.09 mg/L), and symptoms of alveolar hemorrhage and pulmonary emphysema were observed in dogs exposed (as vapors) at 25 ppm for 13 weeks (converted concentration as that of 90-day study: 0.06 mg/L), respectively (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol.8 (2010)). Since the dose levels corresponded to Category 1 of the guidance values, the substance was classified as Category 1 (nervous system, respiratory system). Furthermore, slight anemia and hemosiderin deposition in the spleen were observed in dogs exposed by inhalation at 5 ppm for 26 weeks (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol.8 (2010)). And it was reported that the substance might cause hematologic effects and anemia might occur in humans by exposure for a long-term or repeatedly (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol.8 (2010)). Thus, the substance was classified as Category 1 (blood). Overall, the result of the classification was guided to Category 1 (liver, nervous system, respiratory system, blood).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 2	- -	H401	P273 P501	Classified into Category 2 from its 48h-EC50 = 1.3 mg/L for crustacea (Daphnia magna) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2009).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Classified into Category 2 since its acute toxicity is Category 2 and it is not rapidly degradable (BOD degradation rate: 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2000)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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